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AHRQ's Clancy Discusses Comparative Effectiveness Research/Personalized Medicine Convergence at PMC Conference

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By Turna Ray

In the effort to align personalized medicine and comparative effectiveness research, the Agency for Healthcare Quality & Research will continue to gather evidence on the clinical utility and validity of genetic tests that guide informed healthcare decision making, director Carolyn Clancy said at a recent meeting in Washington, DC.

Speaking at a conference last week hosted by the Personalized Medicine Coalition, Clancy emphasized that AHRQ is in the business of conducting research, not setting healthcare policy. As such, the agency will continue to investigate personalized medicine interventions to inform the work of the Centers for Disease Management and Research's Evaluation of Genomic Applications in Practice and Prevention Working Group. The forthcoming evidence report the AHRQ is planning to release focuses on colorectal screening based on fecal DNA and new biomarkers, Clancy said.

At the same conference, Janet Woodcock, director of the US Food and Drug Administration's Center for Drug Evaluation and Research, said personalized medicine and CER can converge in conducting community-based research. However, for this to occur, the healthcare infrastructure in the US needs to be improved, she said [see PGx Reporter 10-29-2009].

Whether CER and personalized medicine are mutually exclusive concepts was the main topic of discussion at the PMC meeting, where the advocacy organization, in partnership with the Lewin Group, released a report on the very topic. The report recommended areas of alignment for CER and personalized medicine -- such as product labeling, payment policies, and utilization management -- and warned that an inability to converge these issues could lead to "inadequate or misleading" efficacy and safety data about medical interventions [see PGx Reporter 10-28-2009].

Around the same time, NIH Director Francis Collins warned that personalized medicine and comparative effectiveness research were on a potential collision course if heterogeneity of treatment populations is not factored into CER. Collins made his comments at a separate meeting last week hosted by the American Association for the Advancement of Science [see PGx Reporter 10-28-2009].

With around $1.1 billion from the American Recovery and Reinvestment Act dedicated to conducting CER, government agency heads are trying to wrap their heads around the best way to move forward in this area, and the design and scope of CER being one of the most critical components of this effort. Among the beneficiaries of ARRA was NIH with $400 million in funding, AHRQ with $300 million in funds, and the Office of the HHS Secretary with $400 million to create the Federal Coordinating Council for Comparative Effectiveness Research.

With ARRA funding, AHRQ will analyze how readily its CER is considering effectiveness of treatments in specific subpopulations and will determine if the agency's CER methods need to be updated. However, even before receiving ARRA funds, AHRQ was studying the clinical utility and validity of genetic tests, which could provide a springboard for future CER into personalized medicine.

AHRQ conducts evidence reviews at the request of the Office of Public Health Genomics at HHS' Centers for Disease Control and Prevention. The EGAPP, established by OPHG in 2005, will use AHRQ's reports in addition to other evidence to make recommendations on the validity and utility of genetic tests. Currently, EGAPP is using AHRQ's evidence to craft recommendations for testing Factor V Leiden and prothrombin G20210A in deep vein thrombosis. Earlier this year, AHRQ reported finding insufficient evidence that genetic testing of those who have at least one of the two mutations -- FVL and prothrombin G20210A -- helped prevent deep-vein thrombosis or improved clinical outcomes [see PGx Reporter 06-17-2009].

Other evidence reports issued by AHRQ for EGAPP include a report for SSRI genetic testing, ovarian cancer detection and management, gene expression profiling in breast cancer, genetic testing for Lynch syndrome in colorectal cancer patients, and testing for UGT1A1 in colorectal cancer patients treated with irinotecan. In most of its reviews, EGAPP has found limited evidence supporting genetic testing. However, the working group did find sufficient evidence that genetic testing for Lynch syndrome in individuals with newly diagnosed colorectal cancer reduces morbidity and mortality in relatives, and recommends this intervention.

Clancy explained that despite concerns that personalized medicine and comparative effectiveness research have disparate goals, and could work against each other, the two disciplines are aligned in their goals to effectively communicate healthcare information that will improve and guide treatment. In this effort to communicate information to inform better healthcare decisions, Clancy urged for improvements in the way patients and physicians receive and access the latest healthcare information.

She cited existing models of personalized information in the consumer sector, such as Amazon and Pandora, which target information about new books and music based on people's preferences. "So, every time Bruce Springsteen has a new album, I get alerted," Clancy quipped, during the conference. "But I never get anything about Britney Spears." In the same way these online systems personalize information, the delivery of healthcare information should be personalized, Clancy suggested.

One health information technology effort that aims to do just that is the Rapid Learning Project. Based at George Washington University and funded by the Robert Wood Johnson Foundation, the Rapid Learning Project is an effort to develop a national electronic system that links research databases and electronic health records from private and public healthcare providers. The aim of the effort is to learn from real-world patient experience about treatments and adverse reactions, and to apply this knowledge to policy decisions and medical practice.

ARRA provided approximately $19 billion for Medicare and Medicaid Health IT incentives over five years and offered incentives to healthcare providers for moving to an EHR system. In the PMC/Lewin Group report, implementation of health IT and EHR was identified as being instrumental to ensuring that "evidence pertaining to [personalized medicine] is present and actionable at the point of healthcare decisions."

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